Kornimate/medical-research-clean huggingface dataset:
multicenter prospective observational study evaluating the management of heart failure

Conditions: Heart Failure

Summary: adaptation hf is a prospective, observational, cross-sectional, multicenter, survey-based study. patients who applied to the cardiology outpatient clinic with a preliminary diagnosis of hf or were hospitalized for hf and had a diagnosis of hf for at least 6 months will be included in the study.

adaptation hf is a prospective, observational, cross-sectional, multicenter, survey-based study. patients who applied to the cardiology outpatient clinic with a preliminary diagnosis of hf or were hospitalized for hf and had a diagnosis of hf for at least 6 months will be included in the study. data entry staff who will be assigned to the centers for 2 weeks will apply a questionnaire consisting of different questions to the patients referred to them by clinicians with the diagnosis of hf. in addition, pittsburg sleep quality index will be applied to all cases. in addition, clinical features of hf from the current file of the cases (nyha, comorbid conditions, comorbid diseases, blood pressure, heart rate, last drugs used, latest biochemistry (bnp/ntprobnp if available), hematology test results, most recent ecg , most recent echocardiography, coronary angiography report, if available) will be recorded. no additional examination/procedure will be performed for the study, only the data of the examinations requested by the clinician in routine clinical practice will be entered. a total of 500 patients from 10 centers will be included in this study over a six-month period.

Eligibility criteria:
inclusion criteria: * outpatient or inpatient diagnosed with heart failure at least 6 months ago * male or female patient aged 18 and over * signed written informed consent form exclusion criteria: * newly diagnosed heart failure * cry requiring dialysis * serious liver and lung disease * lvad/heart transplantation * hf due to possible temporary cause (myocarditis, peripartum cmp in the first 6 months, takotsubo etc.)

Keywords: heart failure questionnaire echo prospective cross-sectional
efficacy and safety of dapagliflozin in children with proteinuria

Conditions: Proteinuria

Summary: the purpose of the study is to investigate the antiproteinuric effect of dapagliflozin in children with proteinuria.


Eligibility criteria:
inclusion criteria: * age 6 years to 18 years; * urinary protein excretion \> 0.2g in a 24-hr urine collection; * egfr≥60 ml/min/1.73m2; * no history of diabetes; * on stable doses of ace inhibitors or angiotensin receptor blockers (arbs) for \> 1 month; exclusion criteria: * receiving immunosuppressive therapy within three months prior to enrolment. * blood pressure less than 5th percentile of the same gender, age, and height - * leukocyte and/or nitrite positive urinalysis that is untreated; * history of organ transplantation, cancer, liver disease; * evidence of hepatic disease as determined by any one of the following: alt or ast values exceeding 3x uln at the screening visit; * history of noncompliance to medical regimens or unwillingness to comply with the study protocol.

Keywords: proteinuria sglt2i
prevalence of potentially inappropriate treatments

Conditions: Critical Illness; Terminal Illness; Potentially Inappropriate Medication List

Summary: a multicenter point prevalence study in turkish intensive care units.

intensive care units (icu) are life-saving units for critical patients with using advanced technology. in some cases, it becomes a unit where treatment is not possible, the fatal patients are admitted and the death process is extended. most patients with end-stage cancer, advanced-stage chronic obstructive pulmonary disease (copd) and advanced-stage alzheimer's disease prefer to die at home, although many often refer to emergency services at the end of their life and are then transferred to the icu. intensive care treatments are often very invasive and painful interventions. the patient who lives in intensive care unit is faced with many psychological distresses such as communication, isolation and fear besides physical ache. for this reason, it is necessary to make decisions (end-of-life decisions) such as forbearing intensive care treatments applied to the patients in the death process or cutting out the ones started. in the world, the goal for the end of life patients is, improving the last phase of their lives with the application of these decisions and symptom therapy, living in a peace without pain and respiratory distress. however, there is an uncertanity in these issues in our country and intensive care physicians are hesitant to make decisions about the end of life with concern about legal problems. although it is known that these patients will not benefit most from the treatment of icu, they are getting treatments for saving their lives in icus. the fact that intensive care beds are not available due to the patients who are not get beneficial treatment, brings the result of difficult finding of the beds which will benefit from the intensive care, and in fact it is a waste of intensive care resources which is very expensive. the size of the problem is not known as there is no data on the frequency of patients in our country who are in intensive care and require end-of-life care. in this multicenter point prevalence study our aims are; * to find out the incidence of patients in intensive care units in turkey in the last period of life, * to compare the resource use of end-of-life and non-end-of-life patients.

Eligibility criteria:
inclusion criteria: all patients who are over 18 years old, more than 48 hours in the intensive care unit, or expected to be hospitalized exclusion criteria: patients under 18 years of age, less than 48 hours in the intensive care unit stay, or who are monitorized for post-operative care
knee pain phenotypes in the community study

Conditions: Knee Osteoarthritis

Summary: the focus of the study is to determine the prevalence and variance of self-reported knee pain characteristics in a community-derived sample of adults aged 40 years and over. it will also identify characteristics such as structural changes of osteoarthritis of the knee as well as physiological parameters and blood and urine biomarkers.

number of participants: part i: questionnaire to 40,000 people aged 40 years and over (giving an expected 10,000 respondents) part ii: 400 participants.

Eligibility criteria:
inclusion criteria: * aged 40 years and over exclusion criteria: * inability to give informed consent * terminal or mental illness * pregnant women

Keywords: knee pain community study knee osteoarthritis risk factors
a clinical study of tobradex af

Conditions: Cataract

Summary: the purpose of this study is to determine the amount of study medication that moves from the front of the eye into the fluid at the front of the inside of the eye.


Eligibility criteria:
inclusion criteria: * adult patients requiring cataract surgery exclusion criteria: * age related
physical therapy in pre-cystectomy patients

Conditions: Bladder Cancer

Summary: this single-site, non-randomized, study evaluates the impact of a physical therapy consultation for patients with bladder cancer scheduled for radical cystectomy (rc). the purpose of this study is to investigate whether consultation with a physical therapist and the development of a personally tailored exercise program in the pre-cystectomy period for patients with bladder cancer will result in reduced post-operative complications, morbidity, length of inpatient stay, improve readmission 30-day and 90-day and improve 90-day mortality. this study will be partially retrospective (pre-implementation of a physical therapy consultation order) and partially prospective.


Eligibility criteria:
in order to participate in this study a subject must meet all of the eligibility criteria outlined below: inclusion criteria: 1. age ≥ 18 years at the time of bladder cancer diagnosis 2. history of bladder cancer 3. performance of radical cystectomy exclusion criteria: 1. no history of bladder cancer or radical cystectomy

Keywords: radical cystectomy physical therapy exercise program
home administration of flumist by parents/caregivers

Conditions: Influenza

Summary: this study will examine the feasibility of having parents and caregivers administer flumist live intranasal vaccine to their children at home outside the traditional medical environment and without the involvement of medical personnel. the study will recruit patients and families that are already eligible to receive the flumist vaccine. after consent is obtained and vaccine is given to the family, they will go home to administer vaccine to other members within 24 hours. telephone follow up within 48 hours will confirm that vaccine was given successfully and within 9-12 days to assess patient preferences for giving vaccine at home and if there were any adverse events.


Eligibility criteria:
inclusion criteria: 1. the primary caregiver must be 18 years of age or older and willing to give written informed consent for study participation 2. the primary caregiver must be the parent or legal guardian of all the children in living in the household 3. all the children in the household who are 2 through 17 years of age must receive their primary care in the clinic 4. all the children in the household who are 2 through 17 years of age must have private insurance that will provide for the cost of influenza vaccination 5. there must be at least one member of the household who is 2 through 17 years of age, presenting for care in the clinic, eligible to receive live attenuated influenza vaccine (laiv) and whose primary care giver is willing to administer laiv to them in the clinic with supervision 6. there must be at least one family member of the household who is 2 through 17 years of age, not presenting for care in the clinic, eligible to receive laiv and whose primary care giver is willing to administer laiv to them in the in-home setting 7. there must be a working refrigerator in the household 8. the primary caregiver must have a working telephone number and be willing to be contacted for study follow-up by telephone or e-mail 9. the primary caregiver is available for the entire study period - 12 days following the last dose of laiv to be administered to a child 10. the primary caregiver must agree to complete a 30 minute post vaccination assessment and an 8 day diary following vaccination for each child receiving laiv. exclusion criteria: 1. children in the family receive vaccine through vaccines for children program
exploring the familial reach of adolescent obesity treatment

Conditions: Pediatric Obesity

Summary: an observational study ancillary to the randomized clinical trial (rct) teens+ (r01hd095910), a family-based lifestyle intervention, for adolescents with obesity, to determine: 1) if family-wide changes to the shared home environment are implemented, 2) if ripple effects to untreated family members are observed, and 3) whether these changes are predictive of adolescents' weight management success. funding support from nih via r21hd105906.

investigators will recruit non-targeted children (8-17yrs) and caregivers living in the same household as the target teens+ parent/adolescent dyad. at 0, 2, 4 and 8m, the target adolescent/parent dyad (n=60), and non-targeted children and caregivers will complete anthropometric assessments, and measures of the shared home feeding and weight-related environment will be conducted.

Eligibility criteria:
inclusion criteria: * untreated children: must be between 8-17 years of age and primarily living in the same household as the teens+ participants. * untreated caregiver: must be 18 years of age or older and primarily living in the same household as the teens+ participants. * treated caregivers: must have another individual in the household that meets the eligbility for an untreated child or untreated caregiver. exclusion criteria: * temporarily (\<1yr) living in the home * children with a bmi\<5th%ile or caregivers with a bmi\<18.5 kg/m2 * non-english speaking * medical condition(s) that may be associated with unintentional weight change or significant disruption to eating behaviors (e.g., hypothalamic injury, prader-willi, g-tube placement, or malignancy * clinically significant eating disorder (e.g., anorexia nervosa or bulimia nervosa) * following a medically-supervised/prescribed diet * psychiatric, cognitive, physical or developmental conditions that would impair the individual's ability to complete assessments.

Keywords: pediatric obesity lifestyle intervention family-level change family-based intervention
reproductive health in men and women with vasculitis

Conditions: Giant Cell Arteritis; Takayasu's Arteritis; Polyarteritis Nodosa; Wegener's Granulomatosis; Microscopic Polyangiitis; Churg-Strauss Syndrome; Behcet's Disease; Kawasaki Disease; Henoch-schoenlein Purpura; Vasculitis, Central Nervous System; Drug-induced Necrotizing Vasculitis

Summary: the purpose of this study is to learn about reproductive health, including fertility and pregnancies, in people with vasculitis.

all patients enrolled in the vasculitis clinical research consortium's contact registry were invited via email to participate in this study. the contract registry includes people who self-identify as having one of 6 vasculitities: wegener's granulomatosis, microscopic polyangiitis, churg-strauss syndrome, polyarteritis nodosum, takayasu's arteritis, and giant cell arteritis. people voluntarily enroll in this registry with the understanding that they will receive information about clinical studies for which they might be eligible. the introductory email included basic information about the study and all of the required elements for informed consent in a brief format. by clicking the link to the reproductive health questionnaire, participants gave their consent to be included in the study.

Eligibility criteria:
inclusion criteria: * enrolled in vcrc contact registry * patient reported diagnosis of wegener's granulomatosis, microscopic polyangiitis, churg-strauss syndrome, polyarteritis nodosa, takayasu's arteritis, giant cell arteritis, behcet's disease, kawasaki disease, henoch-schoenlein purpura, cns or drug-induced vasculitis * 18 years of age or older * english speaking exclusion criteria: * inability to provide informed consent and complete survey
lentiviral gene therapy for mld

Conditions: Metachromatic Leukodystrophy (MLD)

Summary: this is a phase i/ii clinical trial of gene transfer for treating metachromatic leukodystrophy (mld) using a safety and efficiency improved self-inactivating lentiviral vector tyf-arsa to functionally correct the genetic defect. the primary objectives are to evaluate the safety and efficacy of the gene transfer clinical protocol.

metachromatic leukodystrophy (mld) is a rare lysosomal storage disease. this disease is an inherited single gene autosomal recessive defect. mld is caused by a mutation in the arsa gene encoding arylsulfatase a which leads to a deficiency in sulfatide degradation, resulting in its accumulation in oligodendrocytes, schwann cells and some neurons. a critical level of sulfatide storage can trigger demyelination, the hallmark of mld, which results in multiple neurological symptoms. mld has different onset ages including late infancy (1-2 years), adolescence (4 years-before sexual maturity) and adulthood (after sexual maturity). mld patients are normally rescued by hematopoietic stem cell transplantation (hsct) from a matched healthy donor. however, hsct must be performed at a very early stage of the disease thus restricting its therapeutic opportunies in mld patients. this trial aims to treat mld using a safety and efficiency improved self-inactivating lentiviral vector carrying a functional mld gene to correct the genetic defect by intracerebral injection to delivery the lentiviral vector carrying a normal arsa gene to correct the pathogenic defect. the primary objectives are to evaluate the safety of the improved self-inactivating lentiviral vector tyf-arsa, the in vivo gene transfer clinical protocol and the efficacy of degradative metabolite in patients at the time of treatment, assessment of vector integration sites, and finally the long-term correction of the related pathological symptoms.

Eligibility criteria:
inclusion criteria: 1. mld patient age \>= 0 year 2. arsa gene sequence analysis to confirm mld mutations 3. scoring system for brain mr imaging confirmed mld 4. parent / guardian / patient signing informed consent 5. patients and their families have a strong willingness to participate in clinical trials, and are willing to bear all the consequences caused by the failure of the trial, and sign an informed consent form exclusion criteria: 1. hiv positive patients 2. patients who are experiencing uncontrolled viral, bacterial or fungal infections, malignant tumors, heart abnormalities, liver dysfunction, or renal insufficiency 3. cannot perform an mri 4. infection or dermatosis at pre-injection site 5. any condition that may increase the subjects' risk or interfere with the results of the trial. in addition to mld, there are other neurological disorders.

Keywords: metachromatic leukodystrophy (mld) lentiviral vector
study of hemostasis in patients with congenital disorder of glycosylation

Conditions: Congenital Disorders of Glycosylation

Summary: the purpose of this study is to investigate the coagulation balance in a cohort of congenital disorder of glycosylation (cdg) patients using conventional tests combined with an integrated approach of their coagulation disorders in using tga in the absence or presence of stm. thus, investigators aimed to define if the hemostatic balance in cdg patients, is preserved despite of combined deficiencies in both procoagulant and anticoagulant factors.

in cdg, coagulation abnormalities, affecting both pro and anticoagulant factors, could account for onset of acute microvascular events in these patients. in line with this hypothesis, a previous study reported a correlation between low activity of anticoagulant factors and thrombosis, although stroke-like episodes, the most frequent event, were not analyzed in this study. moreover, the hemostatic balance is usually investigated by global coagulation tests such as the prothrombin time (pt) and the activated partial thromboplastin (aptt). however, these tests have serious limitations. first, they explore only 5 % of the whole generated thrombin, enough to clot the plasma. in addition, global tests are insensitive to the coagulation inhibitors, especially the pc system which cannot be mobilized in the absence of thrombomodulin (tm). the thrombin generation assay (tga), is also a global coagulation assay, but it allows exploration of the whole thrombin formation process from its generation to its inhibition. moreover, combining different analytical conditions, all the anticoagulant systems could be investigated, including antithrombin in basal conditions and the pc system in the presence of soluble tm (stm)

Eligibility criteria:
inclusion criteria: -clinical diagnosis of congenital disorder of glycosylation (cdg) exclusion criteria: - no exclusion criteria

Keywords: stroke-like thrombosis haemorrhages
study of nrx 195183 therapy for patients with relapsed or refractory acute promyelocytic leukemia

Conditions: Acute Promyelocytic Leukemia

Summary: the purpose of this study is to determine whether nrx 195183 is effective in the treatment of relapsed or refractory acute promyelocytic leukemia

a common current therapeutic approach to apl uses oral atra and chemotherapy in induction and consolidation. this approach has significantly improved survival in newly diagnosed apl patients. however, approximately 30% of patients relapse. recently, an approach involving the combination of oral atra and arsenic trioxide has been tested. the prognosis for relapsed patients is very poor. this study seeks to investigate nrx 195183 monotherapy in patients who have failed or are resistant to or are intolerant of any prior therapy.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of apl morphology or fab m3 variant confirmed by rt-pcr assay or chromosome analysis/fish showing t(15:17) translocation. patients must also have relapse from, resistance to or intolerance of any one or more of the following therapies: * atra * cytotoxic chemotherapy * arsenic trioxide * patients must be 18 or older. * bilirubin equal or less than 1.5 times the upper limit of normal. * creatinine equal or less than 1.5 times the upper limit of normal. * patients entered into this study should be non-pregnant and non-nursing and should not plan on becoming pregnant while on treatment. treatment under this protocol would expose an unborn child to significant risks. women and men of reproductive potential should agree to use an effective means of birth control. there is an extremely high risk that a severely deformed infant will result if nrx 195183 is administered during pregnancy. exclusion criteria: * non-apl, aml patients should be excluded from the study. * other serious illnesses which would limit survival to 6 months. * psychiatric conditions which would prevent compliance with treatment or informed consent. * uncontrolled or severe cardiovascular disease. this would include history of a recent acute myocardial infarction, uncontrolled congestive heart failure, or active angina. * aids or hiv positive patients, although hiv test is not required for accrual.

Keywords: acute promyelocytic leukemia cancer leukemia apl atra tretinoid vesanoid retinoic acid receptor alpha all trans retinoic acid arsenic trioxide trisenox retinoid relapsed or refractory acute promyelocytic leukemia
effect of omega-3 fatty acids on insulin sensitivity in chinese gestational diabetic patients

Conditions: Gestational Diabetes

Summary: this study is to examine the change of fasting insulin, glucose, insulin sensitivity and related traits in response to the 14 wk treatment of omega-3 fatty acids, including fish oil (n=25) and flaxseed oil(n=25), in chinese gestational diabetic patients. corn oil(n=25), rich in omega-6 fatty acids, will be selected as a controlled oil. the intervention will start from the third trimester of these pregnant women and finish at the 4wk after the birth of their children. the investigators hypothesize that omega-3 fatty acids could improve insulin sensitivity and glucose metabolism in these patients.


Eligibility criteria:
inclusion criteria: * 1)gestational diabetes 2) female, \<40 years old 3)willing to participant in the trial exclusion criteria: * 1）type 1 diabetes or type 2 diabetes before pregnancy 2）deny to sign the informed consent 3）family history of hypertriglyceridemia or fasting triglyceride\>4.56 mmol/l 4）have severe liver disease, kidney disease or cancer 5)participating in the other clinical trial within 30 days 6)other diseases or conditions, for which the doctor of the patients do not agree his or her participating

Keywords: omega-3 fatty acid gestational diabetes insulin sensitivity